[go: up one dir, main page]

WO2025014867A2 - Dispositifs et procédés de canule à double lumière - Google Patents

Dispositifs et procédés de canule à double lumière Download PDF

Info

Publication number
WO2025014867A2
WO2025014867A2 PCT/US2024/037039 US2024037039W WO2025014867A2 WO 2025014867 A2 WO2025014867 A2 WO 2025014867A2 US 2024037039 W US2024037039 W US 2024037039W WO 2025014867 A2 WO2025014867 A2 WO 2025014867A2
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
lumen
patient
venous
arterial
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/037039
Other languages
English (en)
Other versions
WO2025014867A3 (fr
Inventor
Suraj M. YALAMURI
Atta Behfar
Andrew N. ROSENBAUM
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mayo Foundation for Medical Education and Research
Mayo Clinic in Florida
Original Assignee
Mayo Foundation for Medical Education and Research
Mayo Clinic in Florida
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mayo Foundation for Medical Education and Research, Mayo Clinic in Florida filed Critical Mayo Foundation for Medical Education and Research
Publication of WO2025014867A2 publication Critical patent/WO2025014867A2/fr
Publication of WO2025014867A3 publication Critical patent/WO2025014867A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines

Definitions

  • This document relates to cannula devices for withdrawing venous blood from a patient and returning arterial blood to the patient after extracorporeal oxygenation.
  • this document relates to dual lumen cannula devices and methods for their use with systems such as extracorporeal membrane oxygenation systems.
  • VA-ECMO venoarterial extracorporeal membrane oxygenation
  • peripheral VA-ECMO is achieved by placing the cannulae in the femoral vein and femoral artery to achieve oxygenation with the femoral vein serving as the drainage cannula and femoral artery as the return cannula
  • this technique is limited by several complications, including (1) the risk of rupture of the femoral vessels at the time of access, (2) distal limb ischemia, and (3) risk of hemorrhage.
  • This document describes cannula devices for withdrawing venous blood from a patient and returning arterial blood to the patient after extracorporeal oxygenation.
  • this document describes dual lumen cannula devices and methods for their use with systems such as extracorporeal membrane oxygenation systems.
  • this disclosure is directed to a cannula that includes a proximal portion defining an arterial lumen and a venous lumen that is fluidly distinct from the arterial lumen; a distal portion defining the arterial lumen; and a middle portion extending between the proximal and distal portions.
  • the middle portion defines the arterial and venous lumens.
  • the venous lumen terminates at a distal end of the middle portion.
  • the proximal portion may also define a plurality of first elongate openings through a wall portion of the proximal portion that defines the venous lumen.
  • the middle portion may also define a plurality of second elongate openings through a wall portion of the middle portion that defines the venous lumen.
  • the distal portion may also define a plurality of third elongate openings through a wall portion of the distal portion that defines the arterial lumen.
  • an open area of each first elongate opening of the plurality of first elongate openings is larger than an open area of each second elongate opening of the plurality of second elongate openings.
  • the first elongate openings may extend along spiral paths around a central longitudinal axis of the proximal portion.
  • an outer diameter of the middle portion is smaller than an outer diameter of the proximal portion.
  • an outer diameter of the distal portion is smaller than the outer diameter of the middle portion.
  • a cross-sectional area of the venous lumen of the proximal portion may be larger than a cross-sectional area of the arterial lumen of the proximal portion.
  • the proximal portion may comprise a tubular outer wall and an inner wall that separates the arterial lumen from the venous lumen.
  • a cross-sectional shape of the tubular outer wall is a circle and a cross-section of the inner wall extends along a chord of the circle. In some embodiments, the chord does not intersect a center of the circle.
  • the arterial and venous lumens of the proximal portion may spiral around each other along a longitudinal length of the proximal portion.
  • this disclosure is directed to a method of treating a patient.
  • the method includes inserting a cannula into a femoral vein of the patient and advancing the cannula to a heart of the patient.
  • the cannula comprises: (i) a proximal portion defining an arterial lumen and a venous lumen that is fluidly distinct from the arterial lumen; (ii) a distal portion defining the arterial lumen; and (iii) a middle portion extending between the proximal and distal portions.
  • the middle portion defines the arterial and venous lumens.
  • the venous lumen terminates at a distal end of the middle portion.
  • the proximal portion When the cannula is inserted into the femoral vein and the heart, the proximal portion resides in an inferior vena cava and right atrium of the patient, the middle portion crosses an atrial septum and resides in a left atrium of the patient, and the distal portion extends from a left ventricle and into an ascending aorta of the patient.
  • Such a method may optionally include one or more of the following features.
  • the method may also include drawing venous blood of the patient into the venous lumen of the cannula from: (i) the inferior vena cava, (ii) the right atrium, and (iii) the left atrium.
  • the method may also include supplying arterial blood to the aorta of the patient via the arterial lumen and the distal portion of the cannula.
  • the venous blood and blood from a left atrium, simultaneously drawn from the patient is oxygenated outside of the patient’s body and then returned to the aorta of the patient via the arterial lumen of the cannula.
  • this disclosure is directed to another method of threating a patient.
  • the method includes inserting a cannula into a jugular vein of the patient and advancing the cannula to a heart of the patient.
  • the cannula includes: (i) a proximal portion defining an arterial lumen and a venous lumen that is fluidly distinct from the arterial lumen; (ii) a distal portion defining the arterial lumen; and (iii) a middle portion extending between the proximal and distal portions.
  • the middle portion defines the arterial and venous lumens.
  • the venous lumen terminates at a distal end of the middle portion.
  • the proximal portion resides in a superior vena cava and right atrium of the patient.
  • the middle portion crosses an atrial septum and resides in a left atrium of the patient.
  • the distal portion extends from a left ventricle and into an aorta of the patient.
  • Such a method may optionally include one or more of the following features.
  • the method may also include drawing venous blood of the patient into the venous lumen of the cannula from: (i) the superior vena cava, (ii) the right atrium, and (lii) the left atrium.
  • the method may also include supplying arterial blood to the aorta of the patient via the arterial lumen and the distal portion of the cannula, wherein the venous blood drawn from the patient is oxygenated outside of the patient's body and then returned to the aorta of the patient via the arterial lumen of the cannula.
  • No currently available cannula device is designed for venous only cannulation and aortic outflow in a single device, minimizing the risk of large bore vessel cannulation.
  • the unique serpiginous nature of the drainage and return portions of the dual lumen cannula described herein advantageously provide maximal flow while minimizing the cannula diameter.
  • the devices and methods described herein although technically a “peripheral’’ cannulation technique, advantageously avoid any peripheral arterial cannulation, which is associated with hemorrhagic risk, while at the same time avoids the risk of Harlequin syndrome as the aortic outflow provides anterograde flow, analogous to “central” cannulation.
  • the dual lumen cannulae described herein are adaptable for placement both from the femoral vein and the internal jugular veins, maximizing its utility in practice.
  • FIG. 1 is a cut-away view of a heart and an example dual lumen cannula device in accordance with some embodiments provided herein.
  • FIG. 2 is another cut-away view of the heart and dual lumen cannula device of FIG. 1.
  • FIG. 3 shows various views of a transition portion of the dual lumen cannula device of FIG. 1.
  • FIG. 4 shows various views of a distal portion of the dual lumen cannula device of FIG. 1 .
  • FIG. 5 shows a portion of the dual lumen cannula device of FIG. 1.
  • FIG. 6 shows an example of jugular vein access with the dual lumen cannula devices described herein to provide perfusion to a heart region of a patient.
  • This document describes cannula devices for withdrawing venous blood from a patient and returning arterial blood to the patient after extracorporeal oxygenation.
  • this document describes dual lumen cannula devices and methods for their use with systems such as extracorporeal membrane oxygenation systems.
  • the technology described herein includes a cannula device, and a methodology utilizing the cannula device, to provide complete hemodynamic support incorporating both venous drainage cannula and arterial return cannula in a single cannula device.
  • FIGs. 1-4 show an example cannula 100 in place within a heart H.
  • the cannula 100 extends to the heart H through the inferior vena cava IVC (e.g., from a femoral vein and an external iliac vein).
  • the cannula 100 enters a right atrium RA of the heart H and passes through an opening made in an atrial septum AS of the heart H.
  • the cannula 100 then extends into a left atrium LA, crosses a mitral valve MV, and extends into a left ventricle LV of the heart H. In the left ventricle LV, the cannula 100 turns and crosses the aortic valve AV.
  • the cannula 100 After crossing the aortic valve AV, the cannula 100 extends into the aorta AO. The distal tip of the cannula 100 terminates in the aorta AO.
  • This arrangement can be used for VA-ECMO support, for example, as described further below.
  • the cannula 100 includes a proximal portion 110, a middle portion 120, and a distal portion 130.
  • the middle portion 120 extends between the proximal portion 110 and the distal portion 130.
  • the distal portion 130 terminates at a distal tip of the cannula 100.
  • the proximal portion 110 When positioned in a patient as shown in FIGs. 1 and 2, the proximal portion 110 resides in the inferior vena cava IVC and the right atrium RA.
  • the middle portion 120 passes through the atrial septum AS and resides in the left atrium LA.
  • the distal portion 130 extends through the left ventricle LV, crosses the aortic valve AV, and extends into the aorta AO.
  • the proximal portion 110 has a tubular outer wall 113 (which is circular in cross-section) and an inner wall 114 that separates the venous lumen 111 from the arterial lumen 112.
  • the inner wall 114 extends along a chord of the circular tubular outer wall 113.
  • the inner wall 114 does not pass through a center of the circular tubular outer wall 113 of the proximal portion 110.
  • the length of the inner wall 114 is less than a diameter of the circular tubular outer wall 113. Accordingly, at least in the proximal portion 110, the venous lumen 111 and the arterial lumen 112 have differing cross- sectional areas.
  • the venous lumen 111 has a larger cross-sectional area than the arterial lumen 112.
  • the ratio of the cross- sectional areas of the venous lumen 111 to the arterial lumen ranges from 2: 1 to 2: 1.5, or from 2:0.5 to 2:1.2, or from 2:0.2 to 2:0.8, or from 2:1.4 to 2:1.9, without limitation.
  • the proximal portion 110 defines a plurality of elongated openings 115 (e.g., fenestrations, windows, slits, slots, channel openings, oval shaped openings, etc.) that extends through the tubular wall 1 13 of the proximal portion 1 10 and into the venous lumen 111.
  • elongated shapes can extend either vertically (as depicted) and/or horizontally, or a mixture of both, or at an acute angle between vertical and horizontal across a length of the cannula 100 at the proximal portions 110 and the middle portion 120.
  • the elongate shape of the openings 1 15 helps to reduce shear stress on the blood as it passes through the openings 115 leading to the venous lumen 111.
  • the openings 115 allow venous blood from the patient’s inferior vena cava IVC and right atrium RA to enter into the venous lumen 111. However, none of the openings 115 extends through the inner wall 114 of the proximal portion 1 10 and into the arterial lumen 1 12. Instead, the arterial lumen 112 is a fully continuously sealed lumen within the proximal portion 110.
  • the middle portion 120 includes both the venous lumen 111 and the arterial lumen 112.
  • the venous lumen 111 and the arterial lumen 112 are maintained as separate fluidly distinct lumens throughout the length of the middle portion 120, until the distal end of the middle portion 120.
  • the middle portion 120 defines a plurality of elongate openings 125 (e.g.. fenestrations, windows, slits, slots, channel openings, etc.) that extend through a tubular wall of the middle portion 120 and into the venous lumen 111.
  • the openings 125 allow blood from the left atrium LA of the patient to enter the venous lumen 111 (z.e., LV venting). However, none of the openings 125 extends through the wall of the middle portion 120 and into the arterial lumen 112. Instead, the arterial lumen 112 is a fully continuously sealed lumen within the middle portion 120 and the proximal portion 110.
  • the venous lumen 111 of the proximal portion 110 and the middle portion 120 terminates.
  • the arterial lumen 112 continues into the distal portion 130.
  • the proximal portion 110 and the middle portion 120 are dual lumen cannulae, but the distal portion 130 is a single lumen cannula (with that single lumen being the arterial lumen 112). Accordingly, the size of the cannula 100 reduces at the transition from the middle portion 120 to the distal portion 130.
  • the distal portion 130 is a 14 Fr. or 15 Fr. cannula (without limitation). This transition from the middle portion 120 to the distal portion 130 can be positioned at the mitral valve MV as shown in FIG. 1.
  • the distal portion 130 defines a plurality of elongate openings 135 (e.g., fenestrations, windows, slits, slots, channel openings, etc.) that extend through a tubular wall of the distal portion 130 and into the arterial lumen 1 12.
  • the openings 135 allow arterial blood supplied from the arterial lumen 112 to enter the aorta AO of the patient.
  • the openings 135 are the first and only openings of the arterial lumen 112 through which the oxygen-rich blood can be supplied to the patient via the cannula 100 (i.e.. the arterial lumen 112 is a fully continuously sealed lumen as it passes along within the proximal portion 110 and the middle portion 120).
  • proximal portion 110 is shown to illustrate further the configurations of the venous lumen 111, the arterial lumen 112, and the inner wall 114.
  • the proximal portion 110 illustrated here can also be representative of the middle portion 120 in some embodiments.
  • the heavy arrows in FIG. 5 represent blood flow through the dual lumens 111 , 112 of the proximal portion 110.
  • Arrow 101 represents venous blood flow (i.e., oxygen-depleted venous blood mixed with oxygenated LA blood) through the venous lumen 111
  • arrow 102 represents arterial blood flow (/. e. , oxygenated blood) through the arterial lumen 112.
  • the venous lumen 11 1 and the arterial lumen 112 spiral or twist around each other along the length of the proximal portion 1 10 (and the middle portion 120 in some embodiments). That is the case because the inner wall 114 is configured in a twisted shape, similar to a double helix. It can be said that the blood flow through the proximal portion 110 follows a three-dimensional serpentine or serpiginous course or pathway. This configuration is advantageous because it facilitates both drainage from the entirety of the venous system without risking suction and allows minimization the size of the cannula 100 required for drainage. Increase in the velocity of blood results in concentric flow dynamics.
  • the spiral or twisted blood flow pathways will cause the plasma of the blood to tend to reside on the outer wall of the lumens while the cellular phase of blood red blood cells, platelets, etc.) will be more toward the middle of the cannula 100.
  • the plasma thereby acts like a cushion for the red blood cells to help prevent red blood cell damage and/or thrombosis.
  • FIG. 6 illustrates another example technique for using the cannula 100.
  • the cannula 100 is installed in an internal jugular vein JV and advanced to the heart H via the superior vena cava SVC.
  • the length of the cannula 100 can be shorter than the cannula 100 used for femoral vein access as shown in FIG. 1.
  • the cannula 100 is scalable (in terms of both length and diameters) for various types of usages, patient sizes (including adult and pediatric), and other factors.
  • the area defined by each of individual openings 115 of the proximal portion 110 is larger than the area defined by each of the individual openings 125 defined by the middle portion 120.
  • the area defined by each of the individual openings 135 of the distal portion 130 is smaller than the area defined by each of the individual openings 125 defined by the middle portion 120.
  • the elongate openings 115 of the proximal portion 110 and/or the elongate openings 125 of the middle portion 120 spiral around the central axis of the tubular proximal portion 110 or middle portion 120. In other words, the elongate openings 115/125 can follow a same direction or path that corresponds to the venous lumen 111.
  • Radiopaque markers can be positioned at any of multiple suitable positions on the cannula 100.
  • a series of radiopaque markers are positioned on the transition portion 116 and/or the distal portion 130.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)

Abstract

Des dispositifs de canule peuvent être utilisés pour extraire le sang veineux d'un patient et renvoyer le sang artériel au patient après oxygénation extracorporelle. Par exemple, ce document décrit des dispositifs de canule à double lumière et des procédés pour leur utilisation avec des systèmes tels que des systèmes d'oxygénation par membrane extracorporelle (ECMO). La technologie décrite dans la présente invention comprend un dispositif de canule, et une méthodologie faisant appel au dispositif de canule, pour fournir un support hémodynamique complet incorporant à la fois une canule de drainage veineux et une canule de retour artériel dans un seul dispositif de canule.
PCT/US2024/037039 2023-07-10 2024-07-08 Dispositifs et procédés de canule à double lumière Pending WO2025014867A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363525833P 2023-07-10 2023-07-10
US63/525,833 2023-07-10

Publications (2)

Publication Number Publication Date
WO2025014867A2 true WO2025014867A2 (fr) 2025-01-16
WO2025014867A3 WO2025014867A3 (fr) 2025-04-17

Family

ID=94216317

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/037039 Pending WO2025014867A2 (fr) 2023-07-10 2024-07-08 Dispositifs et procédés de canule à double lumière

Country Status (1)

Country Link
WO (1) WO2025014867A2 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009003044A1 (fr) * 2007-06-26 2008-12-31 Avalon Laboratories, Llc Canule veineuse coaxiale
US9168352B2 (en) * 2011-12-19 2015-10-27 Cardiacassist, Inc. Dual lumen cannula
US10307575B2 (en) * 2017-04-03 2019-06-04 Henry Ford Health System Antegrade hemodynamic support
US20220323663A1 (en) * 2019-08-19 2022-10-13 Reco2Very Therapies Gmbh Cannula Comprising an Expandable Arrangement, Corresponding Cannula System and Method for Inserting at Least One Cannula into a Subject
WO2021037373A1 (fr) * 2019-08-30 2021-03-04 Avidal Group Gmbh Canule d'assistance à un circuit sanguin endovasculaire, ensemble et procédé correspondants
US11701461B2 (en) * 2019-12-12 2023-07-18 National Guard Health Affairs Dual lumen extracorporeal membrane oxygenation catheter with single entry port bypassing the right heart and lungs

Also Published As

Publication number Publication date
WO2025014867A3 (fr) 2025-04-17

Similar Documents

Publication Publication Date Title
US11344659B2 (en) Dual lumen cannula
EP2392370B1 (fr) Cathéter de dialyse
Jayaraman et al. Cannulation strategies in adult veno-arterial and veno-venous extracorporeal membrane oxygenation: techniques, limitations, and special considerations
Pavlushkov et al. Cannulation techniques for extracorporeal life support
EP0983104B1 (fr) Systeme de catheter
US7491163B2 (en) Multilumen catheter for minimizing limb ischemia
US10307575B2 (en) Antegrade hemodynamic support
US6110145A (en) Catheter system for surgical access and circulatory support of the heart
US5254097A (en) Combined percutaneous cardiopulmonary bypass (PBY) and intra-aortic balloon (IAB) access cannula
AU729615B2 (en) Catheter system for surgical access and circulatory support of the heart
US11701461B2 (en) Dual lumen extracorporeal membrane oxygenation catheter with single entry port bypassing the right heart and lungs
WO2025014867A2 (fr) Dispositifs et procédés de canule à double lumière
EP3448453B1 (fr) Dispositifs pour canulation pa-la percutanée et procédés de placement et d'utilisation de ceux-ci
US20250295888A1 (en) Multi-directional flow catheter
Ahmed ECMO Cannulation and Configuration
Arab et al. Variety and Classification of ECMO Systems and Cannulation Strategies
Davis et al. ECMO in lung transplantation
Bermudez et al. ECMO and temporary mechanical circulatory assistance